Relief Reports that its U.S. Collaboration Partner has Presented Evidence that Aviptadil Helps to Prevent Cytokine Storm in Patients with COVID-19

Rhea-AI Summary

Relief Therapeutics reported a significant finding from its partner, NRx Pharmaceuticals, indicating that aviptadil effectively prevents cytokine surges in critically ill COVID-19 patients. This data, derived from a U.S. Phase 2b/3 trial, has been submitted to the U.S. FDA as a supplement for Emergency Use Authorization. NRx is also addressing FDA requests for additional data on this application. Relief is focused on clinical-stage programs, with aviptadil as a lead candidate in late-stage testing against COVID-19 respiratory failure, while also expanding its pipeline through collaborations and acquisitions.

Positive

• Statistically significant data showing aviptadil's effect in preventing cytokine storms released, which could enhance product credibility.
• Submission of findings to the FDA for Emergency Use Authorization may accelerate the approval process for aviptadil.

Negative

• The forward-looking statements in the PR highlight potential risks regarding the approval process by the FDA, which could impact future stock performance.

GENEVA, SWITZERLAND / ACCESSWIRE / July 20, 2021 / RELIEF THERAPEUTICS Holding AG (SIX:RLF, OTCQB:RLFTF) (" Relief "), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (" NRx ") reported in a press release yesterday that it has identified a statistically significant effect of aviptadil in preventing the sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. They reported that the cytokine data were collected as part of the U.S. phase 2b/3 trial of aviptadil compared to placebo in critically ill patients with COVID-19 respiratory failure.

NRx also reported that it has submitted these findings to the U.S. Food and Drug Administration (FDA) as a supplement to its pending application for Emergency Use Authorization (EUA) and is submitting a biomarker letter of intent to the FDA as part of the FDA biomarker program, authorized under the 21 ^st Century Cures Act.

NRx also reported that it continues to respond to FDA information requests for additional data in support of the currently pending EUA application for aviptadil in treating critically ill patients with COVID-19.

The related NRx press release can be accessed through the following link .

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ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief's lead drug candidate, RLF-100 ^TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisition of APR Applied Pharma Research brings a diverse pipeline of marketed and development-stage programs.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com . Follow us on LinkedIn.

CONTACT:
RELIEF THERAPEUTICS Holding AG
Jack Weinstein
Chief Financial Officer and Treasurer
Mail: contact@relieftherapeutics.com

FOR MEDIA/INVESTOR INQUIRIES:
MC Services AG
Anne Hennecke
Tel.: +49 (0) 211-529-252-22
Mail: relief@mc-services.eu

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, and there can be no assurance regarding whether its collaboration partner's application for EUA will be approved by the FDA or that Relief will be successful in obtaining approval for the product in Europe or other territories. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

SOURCE: Relief Therapeutics Holdings AG

View source version on accesswire.com:
https://www.accesswire.com/656235/Relief-Reports-that-its-US-Collaboration-Partner-has-Presented-Evidence-that-Aviptadil-Helps-to-Prevent-Cytokine-Storm-in-Patients-with-COVID-19

FAQ

What did Relief Therapeutics report regarding aviptadil on July 20, 2021?

Relief Therapeutics reported that its partner NRx Pharmaceuticals identified aviptadil's efficacy in preventing cytokine storms in COVID-19 patients, submitting this data to the FDA for Emergency Use Authorization.

What is aviptadil and its current status in clinical trials?

Aviptadil is Relief's lead drug candidate, undergoing late-stage clinical trials in the U.S. for treating respiratory failure due to COVID-19.

What implications does the FDA submission for aviptadil have for investors in RLFTF?

The FDA submission for Emergency Use Authorization may boost investor confidence if it leads to quicker approval and potential market release.